ASCO, the American Society of Clinical Oncology, is winding down their annual meeting. I caught a tweet from a doctor about the findings of a cervical cancer study in India. Have you been around since February? If not, I would strongly suggest reading this post I wrote because I was so outraged at the design of the study.
The LEAD doctor got to share his findings at the ASCO meeting. Thumbprints as acceptable informed consent? Information included in the application completely omitted from the paperwork once the grant was approved for funding by the US government? The study was (is?) under the investigation of the Office of Human Research Protection--a committee that is tasked with making sure there is no unethical use of humans in research.......
What went on in India was unethical. The endpoint of a study was DEATH. Cervical cancer is highly curable and women in India were used as lab rats. One of the first discussions at the ASCO 13 meeting was about the need to fill clinical trials. I agree. Clinical trials save lives. Unless they are poorly designed and despite the poor design, they are allowed to proceed until a whistle blower finds out and questions the whole thing.
Forbes has an article on their website: How Vinegar Could Save 73,000 Women A Year From Cancer. Yes. It's true. But the problem? Women did not have to DIE in the control arm of this study in order to make this determination. Before everyone applauds this doctor for his innovative idea, I think we all need to question how this was allowed to proceed as designed. When justification for the study is defended by words like, "They have no screening anyway, so there is no standard of care (for cervical cancer screening in India)" or "Death is often the endpoint of randomized studies (but when we have curative treatments, should that be allowed)," I am troubled. THEY may not have known better. Quite simply, WE DO and that's a big part of why I am so troubled.
I'm as disgusted today as I was in February when I first learned about the study. I wonder if anyone at the meeting got up to ask the doctor about the investigation and the ethics of true informed consent and setting up a control group of women who were treated as expendable objects rather than human beings. I'm pretty sure we take more precautions with the mice used in experiments in this country than the measures used to protect the women in India.
Here's the link to the overview of the findings which appear as follows:
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